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Diss Factsheets
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EC number: 915-384-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Hydroxylation of lauramide diethanolamine by liver microsomes
- Author:
- Merdink J, deCosta K, Mathews JM, Jones CB, Okita JR and Okita RT
- Year:
- 1 996
- Bibliographic source:
- Drug Metab. Dispos. 24(2):180-186
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Liver and kidney microsomes from DEHP-treated and control rats were incubated with 100 µM test substance for 30 min at 37°C in a shaking water bath. The metabolites were then separated and analysed by GC-MS.
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- EC Number:
- 204-393-1
- EC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Cas Number:
- 120-40-1
- Molecular formula:
- C16H33NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Details on test material:
- - Name of test material (as cited in study report): Lauramide diethanolamine (LDEA)
- Lot/batch No.: Ch1E952
- Locations of the label (if radiolabelling): On the DEA moiety
- Other: Identification by mass spectrometry and proton NMR
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Details on exposure:
- Diethyl hexyl pthalate (DEHP) and control treated liver and kidney microsomes were incubated with 100 µM of test substance for 30 min at 37°C in a shaking water bath according to the method of Okita et al, 1990 .
- Duration and frequency of treatment / exposure:
- 30 min
Doses / concentrations
- Dose / conc.:
- 100 other: µM
- Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES:
- Method of identification: Mass spectral identification (GC/MS).
- Because LDEA contains a 12-carbon side chain, LDEA hydroxylation rates were compared with the hydroxylation rates for lauric acid.
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The test substance was metabolised by rat liver microsomes to two major products that were identified by GC/MS to be the 11- hydroxyl and 12-hydroxy derivatives. The specific activities for 11- and 12-hydroxylation in microsomes prepared from control rats were 2.23±0.40 and 0.71±0.17 nmol/min/mg protein, respectively.
Treatment of rats with the cytochrome P4504A inducer and peroxisome proliferator, diethylhexyl phthalate (DEHP) increased the test substance 12-hydroxylation rate to 3.50 ± 0.48 nmol/mm/mg protein, a 5-fold increase in specific activity, whereas the 11-hydroxylase activity remained unchanged.
The specific activities of 11- and 12-hydroxylation reactions in DEHP treated rats were 1.7-fold and 3.2-fold greater than the 11- and 12-hydroxylation rates, respectively.
Incubating liver microsomes from DEHP-treated rats with a polyclonal anti-rat 4A inhibited the formation of 12-OH-test substance by 80% (3.98±0.10 vs. 0.80±0.08 nmol/min/mg protein), compared with the preimmune serum, but had no inhibitory effect on the rate of 1 1-OH-test substance formation (1.93±0.09 vs. 2.20± 0.11 nmol/min/mg protein).
Rat kidney microsomes also resulted in hydroxylation of the test substance at its 11- and 12-carbon atoms, with specific activities of 0.05±0.01 and 0.28±0.02 nmol/min/mg protein, respectively.
A 5.1-fold increase in specific activity was observed for the test substance l2-hydroxylation reaction after DEHP treatment, whereas the rate for 11-hydroxylation was similar in microsomes from control and DEHP-treated rats.
Any other information on results incl. tables
Other studies: Human liver microsome results: LDEA was also metabolised to 11- and 12-hydroxy derivatives by human liver microsomes at specific activities of 0.22±0.06 and 0.84±0.26 nmol/min/mg protein, respectively.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was rapidly converted into 11- and 12-hydroxy derivatives in rat liver and kidney microsomes.
- Executive summary:
A study was conducted to evaluate the in vitro metabolism of N,N-bis(2-hydroxyethyl)dodecanamide (C12 DEA, also known as LDEA) in liver or kidney microsomes from rat to: 1) determine the extent of its hydroxylation, 2) identify the products formed and 3) examine whether treatment with the cytochrome P4504A inducer and peroxisome proliferator diethylhexyl phthalate(DEHP) would affect hydroxylation rates. Liver and kidney microsomes from DEHP-treated and control rats were incubated with 100 µM LDEA for 30 min at 37°C in a shaking water bath. The metabolites were then separated and analysed by GC-MS. 97% of the hydroxylated products were identified as two major substances: 11- hydroxyl and 12-hydroxy derivatives of LDEA. The specific activities for LDEA 11- and 12-hydroxylation in microsomes prepared from control rats were 2.23±0.40 and 0.71±0.17 nmol/min/mg protein, respectively. Treatment of rats with DEHP increased the LDEA 12-hydroxylation specific activity 5-fold to 3.50 ± 0.48 nmol/mm/mg protein, whereas the LDEA 11-hydroxylase activity remained unchanged. Incubating liver microsomes from DEHP-treated rats with a polyclonal anti-rat 4A inhibited the formation of 12-OH-LDEA by 80% (3.98±0.10 vs. 0.80±0.08 nmol/min/mg protein), compared with the pre-immune serum, but had no inhibitory effect on the rate of 1 1-OH-LDEA formation (1.93±0.09 vs. 2.20± 0.11 nmol/min/mg protein). Rat kidney microsomes also resulted in hydroxylation of LDEA at its 11- and 12-carbon atoms, with specific activities of 0.05±0.01 and 0.28±0.02 nmol/min/mg protein, respectively. In conclusion, under the study conditions, the test substance was rapidly converted into 11- and 12-hydroxy derivatives in rat liver and kidney microsomes (Merdink, 1996).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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